Effect of Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes in Children

Emergence Agitation Clinical Trial

Official title:

Effect of Single-dose Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes After Sevoflurane Anesthesia in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03596775
• Other study ID #: XYFY-2018-0061
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: September 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: September 2018
• Source: Xuzhou Medical University
• Contact: Jin Dong Liu, M.S
• Phone: +86-13951355136
• Email: liujindong1818[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Emergence agitation (EA) is a dissociated state of consciousness in which the child is inconsolable, irritable, uncooperative, typically thrashing, crying, moaning, or incoherent. Although usually transient, it is not only an extremely distressing event for children, parents, and staff, but may also result in self-injury or the need for restraint. The prevalence in children appears to be between 10% and 80% depending upon the definition and measurement tools used and is more frequently observed in the pre-school age-group. A clear correlation has been found between EA and negative postoperative behavioral changes, including anxiety, eating and sleeping disorders, enuresis, fear of darkness, that may persist for an extended period of time affecting emotional and cognitive development.Currently, numerous interventions have been studied to manage EA after surgery. Among them, dexmedetomidine (DEX) as a kind of highly selective α2 adrenergic receptor agonist has been done to reduce EA in children. Unfortunately, no studies examined posthospitalization negative behaviour changes.

Description:

The high incidence of EA and postoperative behavioural changes has encouraged paediatric anaesthetists and researchers to study methods to improve the perioperative care of children. Dexmedetomidine is a selective alpha-2 receptor agonist with properties that make it attractive to pediatric use. It provides sedation and anxiolysis acting on these receptors in the locus ceruleus of the pons. It also exerts dose-dependent moderate primary analgesic effects through activation of alpha-2 adrenoreceptors in the dorsal spinal horn causing a subsequent decrease in substance P release. The study aims to explore whether a single low-dose dexmedetomidine in the perioperative period has a preventive effect on EA in children, and through short-term and long-term follow-up, to investigate the effect on post-hospitalization behavioural changes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: July 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

Inclusion Criteria:

1. Age between 2-7 years old

2. American Society of Anesthesiologists(ASA) score of I or II

3. Selective ear, nose, and throat surgery under general anaesthesia with sevoflurane

Exclusion Criteria:

1. Emergency surgery

2. were intubated before induction of anaesthesia or not planned for extubation after anaesthesia

3. had critical illness with haemodynamic instability, active bleeding, cancer, cardiac diseases including arrhythmias, malignant hyperthermia

4. intellectual disability, or neurological illness with agitation-like symptoms

5. weighed more than 50 kg

6. were allergic to dexmedetomidine

7. The use of sedative or analgesic medications before surgery

Related Conditions & MeSH terms

• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• Dexmedetomidine
Children in Dexmedetomidine group receive intravenous dexmedetomidine 0.5 ug/kg over 10 minutes after induction of anesthesia.
• saline
Children in Control Comparator group receive intravenous saline 10ml over 10 minutes after induction of anesthesia.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

Costi D, Cyna AM, Ahmed S, Stephens K, Strickland P, Ellwood J, Larsson JN, Chooi C, Burgoyne LL, Middleton P. Effects of sevoflurane versus other general anaesthesia on emergence agitation in children. Cochrane Database Syst Rev. 2014 Sep 12;(9):CD007084. doi: 10.1002/14651858.CD007084.pub2. Review. — View Citation

Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-54, table of contents. — View Citation

Pickard A, Davies P, Birnie K, Beringer R. Systematic review and meta-analysis of the effect of intraoperative a2-adrenergic agonists on postoperative behaviour in children. Br J Anaesth. 2014 Jun;112(6):982-90. doi: 10.1093/bja/aeu093. Epub 2014 Apr 11. Review. — View Citation

Silva LM, Braz LG, Módolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: doi:10.2223/JPED.1763. Review. — View Citation

Sun L, Guo R, Sun L. Dexmedetomidine for preventing sevoflurane-related emergence agitation in children: a meta-analysis of randomized controlled trials. Acta Anaesthesiol Scand. 2014 Jul;58(6):642-50. doi: 10.1111/aas.12292. Epub 2014 Mar 3. Review. — View Citation

Tsiotou AG, Malisiova A, Kouptsova E, Mavri M, Anagnostopoulou M, Kalliardou E. Dexmedetomidine for the reduction of emergence delirium in children undergoing tonsillectomy with propofol anesthesia: A double-blind, randomized study. Paediatr Anaesth. 2018 Jul;28(7):632-638. doi: 10.1111/pan.13397. Epub 2018 May 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of EA as assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale	Use the Pediatric Anesthesia Emergence Delirium (PAED) scale to record the incidence of EA.The score ranges from 0 to 20 points. A score of 10 or above is considered as EA.	within 30 minutes after extubation in the post-anaesthesia care unit
Secondary	Pain scores as assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) scale	Use the Face, Legs, Activity, Cry, Consolability (FLACC) scale to record the pain scores. The score ranges from 0 to 10 points. A score of 4 or above is considered as pain.	within 30 minutes after extubation in the post-anaesthesia care unit
Secondary	Rescue analgesia and sedative drug consumption	Rescue analgesia and sedative drug consumption in the post-anaesthesia care unit	within 30 minutes after extubation in the post-anaesthesia care unit
Secondary	Incidence of adverse events	Incidence of adverse events in the post-anaesthesia care unit	within 30 minutes after extubation in the post-anaesthesia care unit
Secondary	Post-hospitalization negative behaviour changes as assessed by the Post Hospitalisation Behaviour Questionnaire (PHBQ) scale	Use the Post Hospitalisation Behaviour Questionnaire (PHBQ) scale to record the incidence of Post-hospitalization negative behaviour changes.This consists of 27 items describing six subscales: general anxiety, separation anxiety, sleep anxiety, eating disturbances, aggression against authority and apathy/withdrawal.The possible answers were provided on a scale from 1 to 5 ('much less', 'less', 'unchanged', 'more' or 'much more' than before hospitalisation).A score of 0 was awarded if no negative behaviour was reported either before or after surgery.Total score was calculated by adding up all responses.	1 day, 2 days,30 days post surgery